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A Multicenter, Randomized, Single-blind, Active-controlled, Parallel Group, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of a Single Intravenous (6 mg, 12 mg, 18 mg, 24 mg or 36 mg) Dose of the Neurokinin-1 Receptor Antagonist, Vestipitant (GW597599), Compared With a Single 4 mg Intravenous Ondansetron Hydrochloride Dose for the Treatment of Breakthrough Post-Operative Nausea and Vomiting After Failed Prophylaxis With an Ondansetron-Containing Regimen in Patients Undergoing Non-Emergency Surgical Procedures.

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Trial Profile

A Multicenter, Randomized, Single-blind, Active-controlled, Parallel Group, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of a Single Intravenous (6 mg, 12 mg, 18 mg, 24 mg or 36 mg) Dose of the Neurokinin-1 Receptor Antagonist, Vestipitant (GW597599), Compared With a Single 4 mg Intravenous Ondansetron Hydrochloride Dose for the Treatment of Breakthrough Post-Operative Nausea and Vomiting After Failed Prophylaxis With an Ondansetron-Containing Regimen in Patients Undergoing Non-Emergency Surgical Procedures.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 31 Aug 2023

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At a glance

  • Drugs Vestipitant (Primary) ; Ondansetron
  • Indications Postoperative nausea and vomiting
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PONV

Most Recent Events

  • 01 Aug 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
  • 19 Jun 2012 Additional lead trial investigators identified as reported by ClinicalTrials.gov.
  • 15 Jun 2012 Additional trial location (Scotland) added as reported by United Kingdom Clinical Research Network record.

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